CN114430688A

CN114430688A - Holder for medical devices

Info

Publication number: CN114430688A
Application number: CN202080068956.9A
Authority: CN
Inventors: H·利斯特; F·韦霍夫斯基
Original assignee: F Hoffmann La Roche AG
Current assignee: F Hoffmann La Roche AG
Priority date: 2019-10-01
Filing date: 2020-09-29
Publication date: 2022-05-03
Also published as: US20220218283A1; EP4037546A1; IL291790A; WO2021063905A1

Abstract

A holder (110) for a medical device (112) is described. The medical device (112) comprises at least one percutaneously insertable portion and at least one housing (162). The holder (110) comprises: -at least one mounting device (114), wherein the mounting device (114) comprises at least one first side (122) and at least one opposite second side (124), wherein the mounting device (114) further comprises at least one hole (138) from the first side (122) to the second side (124), wherein the mounting device (114) is configured to be connected to the housing (162) of the medical device (112); and-at least two straps (116), wherein the straps (116) are attached to the mounting device (114), respectively, wherein the two straps (116) are fixedly connectable to each other.

Description

Holder for medical devices

Technical Field

The present invention relates to a holder for a medical device, a kit and a method for mounting a medical device on a skin site of a user's limb. The device and method according to the invention may primarily allow the transcutaneous sensor and the housing of the transcutaneous sensor to be adhered to a skin site of a user or patient. Furthermore, the device and method according to the present invention may allow a drug device, such as an insulin pump, to be adhered to a skin site of a user or patient. Other applications are generally possible.

Background

The delivery of drugs, in particular insulin, to the user plays an important role in the prevention and treatment of diseases, in particular the treatment of diabetes. In addition to using an injection pen or syringe, insulin pumps may be used for specialized insulin delivery. In particular, users often need to wear insulin pumps on the body at all times. A common pump for delivering a drug, such as, for example, insulin, includes one or more drug containers. As an example, a fluid delivery device is disclosed in WO2011/046950 a 1.

Furthermore, in the field of medical technology and diagnostics, a large number of devices and methods are known for determining the presence and/or concentration of one or more analytes in a sample, in particular a fluid sample, such as a body fluid, and/or for determining at least one parameter of the sample. For performing fast, simple measurements, several types of test elements are known, which are mainly based on the use of one or more test chemicals, i.e. on the use of one or more chemicals, one or more compounds or one or more chemical mixtures, which are suitable for performing a detection reaction to detect an analyte or to determine a parameter. The test chemical is also commonly referred to as a test substance, a test reagent, a test chemical composition, or as a detection substance. Continuous measurements are increasingly being established, in addition to so-called single-point measurements, i.e. the taking of a body fluid sample from a user in a targeted manner and the checking of the analyte concentration. Therefore, continuous measurement of glucose in, for example, the interstitial tissue (also known as continuous monitoring, CM) has been established for some time recently as another important method for managing, monitoring and controlling the diabetic state. In this process, the active sensor region is applied directly to a measurement site, which is usually arranged in the interstitial tissue, and glucose is converted into an electrical charge, which is related to the glucose concentration and can be used as a measurement variable, for example by using an enzyme (e.g. glucose oxidase, GOD). Examples of such transcutaneous measurement systems are described in US 6,360,888B 1 or US 2008/0242962 a 1. Thus, current continuous monitoring systems are typically either transcutaneous or subcutaneous systems, where both expressions will be used equivalently below. This means that the actual sensor, or at least the measuring part of the sensor, is arranged under the skin of the user.

In general, a medical pump and a device configured to determine the presence and/or concentration of one or more analytes in a sample may be configured to be attached to a skin site of a user or patient. To this end, generally, at least one surface of the medical pump and the device configured to determine the presence and/or concentration of one or more analytes in the sample may include at least one adhesive material configured to attach to a skin site of a user or patient. Typically, the medical pump and the device configured to determine the presence and/or concentration of one or more analytes in a sample are typically left on the skin site for several days, such as for a period of two to five days or even one to two weeks, respectively. Because the manufacturing costs of devices configured to determine the presence and/or concentration of one or more analytes in a sample are typically high, such devices are typically intended to be used for as long as possible, particularly because healthcare systems typically refund only the equivalent of a few test strips per day. Generally, the appeal of such devices increases as they are able to replace as many test strips as possible.

Devices, systems, methods and kits for releasably mounting a medical device on the body or skin of a user are described in US 2011/319733 a 1. In particular, a structure suitable for mounting a medical device on a host body is described. The structure includes a first portion and a second portion movable relative to the first portion. When operatively mounted thereto, movement of the second portion relative to the first portion releases at least a portion of the medical device from the first and second portions.

In US 2018/0348048, systems and methods are described for mounting optical sensors in a physiological monitoring device worn by a user to sense, measure and/or display physiological information. The optical sensor may be mounted in the back of the device, emit light near a target area of the user's body, and detect light reflected from the target area. The optical sensor may be mounted in the housing or the back cover such that at least a portion of the optical sensor protrudes a distance from at least a portion of the housing. The protrusion distance may be adjustable such that the user may achieve a customized fit of the wearable device. Adjustment of the protrusion distance may also result in a customized level of contact and/or pressure between the optical sensor and the target area, which in turn may result in more reliable and accurate sensing of physiological information.

Despite these advantages of the prior art devices, there are some technical challenges. In particular, many users or patients are unable to use medical pumps and devices configured to determine the presence and/or concentration of one or more analytes in a sample due to skin intolerance to the adhesive of the housing of the medical pump or the device configured to determine the presence and/or concentration of one or more analytes. The skin site may be irritated within only a few days or even hours after the medical pump or device configured to determine the presence and/or concentration of one or more analytes is installed on the skin site via the adhesive material. As a result, a user or patient may remove the medical pump or the device configured to determine the presence and/or concentration of one or more analytes from the skin site, even though the useful life of the medical pump or the device configured to determine the presence and/or concentration of one or more analytes has not expired.

Problems to be solved

It is therefore an object of the present invention to provide a holder for a medical device, a kit and a method for mounting a medical device on a skin part of a user's limb, which at least partly avoid the disadvantages of known devices and methods of this kind and at least partly solve the above-mentioned challenges. In particular, a device and a method will be disclosed which allow adhering a medical device, in particular a housing of a medical device, to a skin site of a patient or user and which at the same time will avoid the risk of the skin of the patient or user being intolerant to the adhesive of the medical device housing.

Disclosure of Invention

This problem is solved by a holder for a medical device, a kit and a method for mounting a medical device on a skin site of a user's limb having the features of the independent claims. In the dependent claims and throughout the description advantageous embodiments are listed, which can be realized in a single way or in any combination.

As used hereinafter, the terms "having," "including," or "containing," or any grammatical variations thereof, are used in a non-exclusive manner. Thus, these terms may refer both to the case where no additional features are present in the entity described in this context, in addition to the features introduced by these terms, and to the case where one or more additional features are present. As an example, the expressions "a has B", "a includes B" and "a includes B" may refer both to the case where, in addition to B, no other element is present in a (i.e. the case where a consists solely and exclusively of B), and to the case where, in addition to B, one or more further elements are present in entity a (such as element C, element C and element D or even further elements).

In addition, it should be noted that the terms "at least one," "one or more," or similar expressions indicating that a feature or element may exist one or more times are used only once when the corresponding feature or element is introduced. In the following, in most cases, when referring to corresponding features or elements, the expression "at least one" or "one or more" will not be repeated, although the corresponding features or elements may be present only once or more than once.

In addition, as used hereinafter, the terms "preferably," "more preferably," "particularly," "more particularly," "specifically," "more specifically," or similar terms are used in conjunction with the optional features, without limiting the possibilities of alternatives. Thus, the features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. As those skilled in the art will appreciate, the invention may be implemented using alternative features. Similarly, a feature introduced by "in one embodiment of the invention" or a similar expression is intended to be an optional feature, without any limitation to the alternative embodiments of the invention, without any limitation to the scope of the invention, and without any limitation to the possibility of combining the feature introduced in this way with other optional or non-optional features of the invention.

The terms "patient" and "user" as used herein are broad terms and are given their ordinary and customary meaning to those of ordinary skill in the art, and are not limited to special or customized meanings. The term may particularly refer to, but is not limited to, a human or an animal, irrespective of the fact whether the human or animal, respectively, is likely to be in a healthy condition or may be suffering from one or more diseases. As an example, the patient or user may be a human or animal suffering from diabetes. However, the invention may additionally or alternatively be applied to other types of users or patients or diseases.

In a first aspect of the invention, a holder for a medical device is disclosed. The medical device comprises at least one percutaneously insertable portion and at least one housing. The holder comprises at least one mounting device. The mounting device includes at least one first side and at least one opposing second side. The mounting device further includes at least one aperture from the first side to the second side. The mounting device is configured to be coupled to the housing of the medical device. Furthermore, the holder comprises at least two straps. The straps are attached to the mounting means, respectively. The two straps may be fixedly connected to each other.

As used herein, the term "medical device" is a broad term and is to be given its ordinary and customary meaning to those of ordinary skill in the art, and is not to be limited to a special or customized meaning. The term may particularly refer to, but is not limited to, any device configured to perform at least one therapeutic purpose. The medical device may particularly comprise one component or an assembly of two or more components capable of interacting with each other, such as for performing one or more therapeutic purposes, such as for performing a medical procedure. Medical devices may also be generally referred to as medical systems.

The medical device may be selected from the group consisting of: a drug device for delivering at least one drug to a user; a medical device for detecting at least one analyte in a bodily fluid. However, other applications may also be possible.

A drug device for delivering at least one drug, such as a drug and/or therapeutic agent, to a user may be used as part of one or more medical treatments. The drug device for delivering at least one drug to a user may illustratively be selected from the group consisting of: medical pump, in particular insulin pump. However, other embodiments of the drug device may also be possible.

Furthermore, the medical device may be a medical device for detecting at least one analyte in a body fluid. As further used herein, the term "detecting" refers to the process of determining the presence and/or amount and/or concentration of at least one analyte. Thus, the detection may be or may comprise a qualitative detection, which simply determines the presence or absence of the at least one analyte, and/or may be or may comprise a quantitative detection, which determines the amount and/or concentration of the at least one analyte. As a result of the detection, at least one signal, such as at least one measurement signal, may be generated that is characteristic of the detection result.

In particular, the medical device may have a percutaneously insertable portion. As used herein, the term "percutaneously insertable portion" refers to a component, such as a portion of any device, that is adapted to be disposed entirely or at least partially within a body tissue of a patient or user. For this purpose, the percutaneously insertable portion may generally be dimensioned such that percutaneous insertion is feasible, such as by providing a width in a direction perpendicular to the insertion direction of not more than 5 mm, preferably not more than 2 mm, more preferably not more than 1.5 mm. The percutaneously insertable portion may have a length of less than 50 mm, such as a length of 30 mm or less, e.g. a length of 5 mm to 30 mm. However, it should be noted that other dimensions are possible. The percutaneously insertable portion may fully or partially provide a biocompatible surface, i.e. a surface which does not have any detrimental effect on the user, the patient or body tissue, at least during use.

As used herein, the term "insertable portion" is a broad term and is given its ordinary and customary meaning to those of ordinary skill in the art, and is not limited to a special or customized meaning. The term may particularly, but not exclusively, refer to any of the following component parts: the optional component portion may be configured to be at least partially insertable into another object such that the insertable portion may be at least partially positioned beneath the object or enclosed by an interior of the object. In particular, the insertable portion may be configured to be at least partially inserted into body tissue, in particular under the skin of a patient. Thus, the insertable portion may particularly have an elongated shape with a small cross-section.

Illustratively, the percutaneously insertable portion may be selected from the group consisting of: a sensor, preferably an analyte sensor for detecting at least one analyte in a body fluid, preferably a glucose sensor; an infusion cannula, preferably an insulin infusion cannula. However, other embodiments may also be possible. As further used herein, the terms "sensor" and "analyte sensor" may refer to any element suitable for use in a detection process. The sensor may illustratively be an electrochemical sensor having at least two electrodes. The sensor may specifically be a glucose sensor.

As outlined above, the percutaneously insertable portion may be an infusion cannula. The term "infusion cannula" may generally refer to any cannula configured to introduce an infusate (i.e., a liquid substance, particularly a drug-containing liquid substance) into body tissue. Thus, the infusion cannula may be attached to a container containing a liquid substance, in particular via the extracorporeal proximal end of the infusion cannula.

The percutaneously insertable portion may have an elongated or rounded form. In particular, the percutaneously insertable portion may have the form of a cylinder, in particular one of the circular cylinders. Further, the percutaneously insertable portion may have a rectangular cross-section or a trapezoidal cross-section. The percutaneously insertable portion may have an outer diameter of 0.25 mm to 1.5 mm, preferably 0.5 mm to 1 mm, preferably about 0.65 mm, more preferably 0.67 mm.

The medical device may be configured to be mounted on a skin site of a limb of a user. The limb may be selected from the group consisting of: an arm, in particular an upper arm; the abdomen; a shoulder portion; a back; the buttocks; and (4) a leg part. In particular, the limb may be the upper arm. However, other applications may also be possible.

The medical device may further include at least one component that may be configured to reside outside of the body tissue. In particular, the medical device may comprise at least one housing. The housing may correspond to a component that may be configured to reside outside of body tissue. As used herein, the term "housing" is a broad term and is given its ordinary and customary meaning to those of ordinary skill in the art, and is not limited to a special or customized meaning. The term may particularly refer, but is not limited to, an element or component having at least one interior space and at least one wall that completely or partially encloses and provides protection to the interior space, such as one or more mechanical protections or protection from environmental influences, such as one or more of moisture, oxygen or microbial contamination. The housing may generally be adapted to fully or partially enclose and/or receive one or more elements so as to provide one or more of the following: mechanical protection, mechanical stability, environmental protection against moisture and/or ambient atmosphere, shielding against electromagnetic influences, etc. The housing may also provide a foundation for attaching and/or holding one or more additional components or elements.

In particular, the housing may be configured to hold one or more electronic components. Therefore, the housing may also be referred to as an electronic unit. In particular, if the medical device is a medical device for detecting an analyte in a body fluid, the electronic unit may be configured to one or more of: determine and/or control the detection of the analyte, or transmit measurement data to another component. The term "detecting" generally refers to the process of determining the presence and/or amount and/or concentration of at least one analyte. Thus, the detection may be or may comprise a qualitative detection, which simply determines the presence or absence of the at least one analyte, and/or may be or may comprise a quantitative detection, which determines the amount and/or concentration of the at least one analyte. In particular, the electronic component may be configured as one or more of: performing measurements using the sensor, performing voltage measurements, performing current measurements, recording sensor signals, storing measurement signals or measurement data, transmitting the sensor signals to another component. Thus, the electronic unit may particularly comprise at least one of: voltmeter, ampere meter, potentiostat, voltage source, current source, signal receiver, signal transmitter, analog-to-digital converter, electronic filter, data storage device, energy storage device. In particular in case the medical device is a drug device for delivering a drug to a user, the housing may be an infusion set with a pump for transferring an infusate into the body tissue of the user or patient. Other embodiments of the housing may be possible.

The housing may particularly be embodied as a closed electronic unit. The percutaneously insertable portion may be at least partially enclosed by a housing.

In an embodiment, the housing may include at least one mounting unit. The mounting unit may serve as a support for other components of the medical device, such as the percutaneously insertable portion and/or the electronic component.

However, in particular, the housing may not include the mounting unit. In this case, the housing may be further configured to attach directly to a skin site of a user or patient. Thus, the housing may comprise at least one attachment means capable of forming a connection with the skin site, such as at least one adhesive surface and/or at least one adhesive strip or paste.

As used herein, the term "holder" is a broad term and is given its ordinary and customary meaning to those of ordinary skill in the art, and is not limited to a special or customized meaning. The term may particularly refer to, but is not limited to, an element that holds another object in a desired position. In particular, the holder may be configured to fix the object, in particular to be mounted to a further object. Thus, as a result, the object may be mounted on, in particular attached to, a further object via the holder. When the object is held by the holder, a movement or displacement of the object relative to the holder may be prevented, at least to a large extent. Thus, by rotation, displacement or other movement of the holder, the object may be left on the holder. The holder may generally be configured to establish an adhesive bond with the object. Thus, the holder may also be referred to as a mount, mounting support or support.

The holder may be configured to wrap around a limb, in particular around an arm. As outlined above, the limb may specifically be the upper arm. The limb may correspond to a body part where the medical device is to be placed. The holder may provide a surface formed and dimensioned to receive a medical device. The strap may be sized to wrap around the limb. The holder may specifically comprise a length of 200 mm to 2000 mm, preferably 300 mm to 1500 mm, more preferably 400 mm to 600 mm. Furthermore, the strip of the holder may comprise a width of 10 mm to 300 mm, preferably 15 mm to 60 mm, more preferably 20 mm to 40 mm. Other dimensions may be possible.

The holder may particularly be embodied as an elongated object, which may be configured to enclose or enclose a structure, which encloses or encloses a limb, particularly an upper arm. The holder may in particular be a three-dimensional structure configured to at least partially encompass the limb. The distance between the surface of the limb, in particular the skin part of the user or patient, and the surface of the holder may have a constant value. In particular, a surface of the holder may be configured to be in direct contact with a surface of the limb. As used herein, the term "at least partially encompasses" may generally refer to a situation in which one object a surrounds the circumference of another object B at least one location or section of the object B.

The holder may specifically be a flexible holder. As used herein, the term "flexible holder" is a broad term and is given its ordinary and customary meaning to those of ordinary skill in the art, and is not limited to a special or customized meaning. The term may particularly refer to, but is not limited to, any holder having a portion that is capable of being bent or deformed by forces (such as 10N or less) that typically occur during holding of the portion of the holder with two hands and moving the hands relative to each other. In particular, the flexible holder may be made of or may comprise at least one deformable material, such as at least one plastic or malleable material and/or at least one elastic material. The flexible holder may in particular be reversibly deformable and may at least partially return to its original shape when the applied stress is removed. The holder may particularly be partially flexible. Thus, the holder may have a portion with stiff or rigid properties. In particular, the strap may be at least partially flexible, and the mounting means may be implemented as a stiff component, which will be described in more detail further below. However, other embodiments may also be possible.

As outlined above, the holder comprises a mounting device. As used herein, the term "mounting device" is a broad term and is to be given its ordinary and customary meaning to those of ordinary skill in the art, and is not to be limited to a special or customized meaning. The term may particularly refer, but is not limited to, a device configured to mount any object, particularly fixed or attached to another element, particularly in a desired position. Thus, as a result, the object can be mounted, in particular fixed or attached, to the other element via the mounting means. When the object is held by the mounting device, a movement or displacement of the object can be prevented, at least to a large extent. Thus, the object may be left on the mounting device by rotation, displacement or other movement of the other element. In particular, the object may refer to a housing of a medical device as described above or as will be described in more detail further below. Further, other elements may refer to a limb of a user or patient. Thus, the mounting device may generally be configured to establish an adhesive bond with the housing of the medical device. Further, the mounting device may generally be configured to establish at least one of a form fit, a pressure fit connection, or an adhesive bond with the limb of the user or patient. Thus, the mounting device may be configured as a connection or coupling element between the housing of the medical device and the limb of the user or patient. In particular, in the mounted state of the housing of the medical device to the limb, the mounting device may remain in form-fitting and/or press-fitting connection and/or adhesive bond with the housing and the limb, respectively. Thus, in the mounted state, the mounting device itself may be fixedly attached to at least one of the shell, the limb. Other embodiments are possible. The mounting device may be implemented as a component of the holder. Therefore, the mounting means may also be referred to as a mounting portion.

As outlined above, the mounting device comprises a first side and an opposite second side. As used herein, the term "side" is a broad term and is given its ordinary and customary meaning to those of ordinary skill in the art, and is not limited to a special or customized meaning. The term may particularly refer to, but is not limited to, different surfaces forming the exterior of any object. The terms "first side" and "second side" may be considered merely as nomenclature, without numbering or ordering the named elements, without specifying an order and without excluding the possibility that several first and second sides exist. Further, there may be additional sides, such as one or more third sides.

The first and second side may particularly refer to the longitudinal sides of the holder, respectively. Thus, the shorter sides of the holder may extend transversely, in particular perpendicularly, to the first and second side, respectively. The second side may particularly refer to a rear side of the holder, and the first side may particularly refer to a front side of the holder. In a mounted state of the holder, wherein the holder is fixedly connected to a limb of a user or patient, the second side may face a skin part of the user or patient and the first side may face an external environment of the user or patient.

Further, the medical device may be attached to the holder on the first side. The first side of the mounting device may particularly comprise at least one flat surface configured to attach a medical device. In turn, the medical device, in particular the housing of the medical device, may have at least one flat medical device surface. The planar surface of the first side of the mounting device and the planar medical device surface of the medical device may be configured to overlie one another. The flat surface of the first side of the mounting device and the flat design of the flat medical device surface of the medical device, respectively, may lead to a large contact area between the medical device and the holder, in particular between the mounting device of the holder and the housing of the medical device, and to a stable connection between the medical device and the holder.

In particular, the flat surface may be a rough surface, in particular a slightly rough surface. This may lead to an improved adhesion of the medical device to the holder, in particular the housing of the medical device to the mounting means of the holder. In particular, the rough surface may have a roughness of 0.2 μm to 100 μm, preferably 0.4 μm to 50 μm, more preferably 1 μm to 10 μm. Alternatively, the flat surface may be a smooth surface and may in particular be manufactured as a single piece. The planar surface may be made of at least one material selected from the group consisting of: polyurethane, neoprene. Other materials are also possible. In particular, the flat surface may be made of at least one material having a shore a hardness of 60 to 100, preferably 70 to 90.

As outlined above, the second side of the mounting device may be configured to face a skin site of a user or patient. Only optionally, the second side may comprise at least one adhesive material. The adhesive material may be configured to secure the holder, in particular the mounting means of the holder, to the skin site during insertion of the transcutaneous insertion portion. The adhesive material may be configured to adhere to the skin site for only a few minutes. In particular, the adhesive material need not adhere to the skin site for several days. After insertion, the medical device may be held in place by the holder, in particular by a strap encircling the limb, as will be described in more detail further below. Thus, skin irritation can be reduced.

Further, optionally, the second side may be coated with or may comprise at least one of soft silicone rubber, dense foam rubber, neoprene rubber. Thus, the fixation of the holder, in particular the mounting means of the holder, to the skin site during insertion of the percutaneously insertable portion may be improved.

The mounting means may in particular be embodied as a flat means having a lateral extension exceeding its thickness by at least 2 times, at least 5 times, at least 10 times or even at least 20 times or more. The mounting means may in particular have a circular shape. The shape of the mounting device may correspond to the shape of the medical device, in particular to the shape of the medical device defined by a contact area of the medical device, which contact area is configured to rest on the mounting device. However, other shapes may be possible.

The mounting means may have a thickness of 0.1 mm to 2 mm, preferably 0.3 mm to 1 mm, preferably 0.4 mm to 0.7 mm, most preferably 0.5 mm. The term "thickness" may generally refer to the lateral extension of any device in one direction. In particular, the term "thickness" may refer to a lateral extension of the mounting device transverse, in particular perpendicular, to the extension direction of the mounting device. The low profile design of the mounting device may be particularly advantageous, since typically the medical device is configured to be directly attached to a skin site of a patient or user via an adhesive material. The thickness may be related to the lateral extension of the mounting device without considering the collar comprised in the holder in one embodiment.

Furthermore, the mounting means may be at least partially made of a rigid material. The term "rigid material" generally describes the characteristic of any solid material that is not capable of bending deformation. Thus, the rigid material can resist deformation independent of the amount of stress applied to the rigid material. Thus, the strain may be zero or at least close to zero and the young's modulus may be > 1000 MPa. Thus, high stability can be provided for the medical device. The mounting means may be made of a thermoplastic and/or rigid plastic material, in particular a material selected from the group consisting of: polycarbonate (PC), Polyurethane (PU), polycarbonate-acrylonitrile-butadiene-styrene blend (PC-ABS blend). Other materials are also possible. Furthermore, hard rubber materials having a Shore A hardness of at least 90 may also be suitable.

As outlined above, the mounting means comprises at least one hole from the first side to the second side. As used herein, the term "aperture" is a broad term and is given its ordinary and customary meaning to those of ordinary skill in the art, and is not limited to a special or customized meaning. The term may particularly refer to, but is not limited to, an opening, cavity or hollow space within any object. The hole may particularly have a circular reinforcement shape. However, other shapes may be possible. In particular, the hole may be a through hole. The term "through-hole" may generally refer to a hole of any object that penetrates completely through the object. The object may have at least two opposite sides, and the through-hole may extend from one of the two sides to the other of the two sides so as to penetrate each of the two sides. Thus, the through hole may form a connection between the two sides. The hole may be located particularly in the centre of the mounting means. For example, the mounting means may have a circular shape and the position of the hole may correspond to the centre of the circle. However, other locations of the holes may also be possible. The housing of the medical device as described above may comprise at least one opening, in particular at least one through opening. The opening may be positioned on a side of the housing configured to attach to a mounting device of the retainer. The opening may be configured to release the percutaneously insertable portion from the interior space of the housing to an environment external to the housing. In a state in which the medical device is mounted on the holder, in particular on the mounting device, the opening of the medical device housing and the hole of the mounting device may be arranged congruent. The aperture of the mounting device may be configured to guide the transcutaneous insertion portion from a first side of the mounting device to a second side of the mounting device. Thus, the percutaneously insertable portion may penetrate a skin site of a user or patient.

As outlined above, the mounting device is configured to be connected to a housing of a medical device. As used herein, the term "configured to be connected to" is a broad term and is given its ordinary and customary meaning to those of ordinary skill in the art, and is not limited to a special or customized meaning. The term may particularly refer to, but is not limited to, the property that an object can be placed into and physically next to another object. In particular, an object configured to be connected to another object may be in direct or indirect physical contact with the other object when connected to the other object. In particular, the housing of the medical device may have an attachment member, such as the at least one adhesive surface and/or the at least one adhesive strip or paste, capable of connecting the housing to the skin site. The adhesive surface of the housing may be configured to attach to a mounting device of the holder, in particular to a first side of the holder. Thus, the mounting device and the housing may be connected to each other.

In particular, the holder may comprise at least one collar. As used herein, the term "collar" is a broad term and is given its ordinary and customary meaning to those of ordinary skill in the art, and is not limited to a special or customized meaning. The term may particularly refer to, but is not limited to, a portion of any object that may surround the object in at least two dimensions. The collar may form a protrusion on the object. Thus, the collar may protrude from the surface of the object.

The collar may be arranged on the first side of the mounting device. In particular, the collar may form a protrusion on the first side. In a cross-sectional view transverse, in particular perpendicular, to the extension direction of the mounting means, the collar may define a cross-sectional profile. The cross-sectional profile may be spherical or may be elliptical. However, other shapes may be possible. The collar may have a height of 0.5 mm to 6 mm, preferably 1 mm to 4 mm, more preferably 1.5 mm to 3 mm. The height may depend on the size of the medical device. The term "height" may refer to the distance between the surface of the mounting device and the point of the collar furthest from the surface of the cross-sectional profile of the mounting device.

As used herein, the term "strap" is a broad term and is given its ordinary and customary meaning to those of ordinary skill in the art, and is not limited to a special or customized meaning. The term may particularly refer to, but is not limited to, any elongated element of flexible material. In particular, the strip may be implemented as a strip. The straps may be configured to fasten or hold articles together. Further, the straps may be configured to form an endless belt by themselves or with other straps and/or elements. However, other applications may be possible. Furthermore, the strip may in particular be embodied as an enclosing or enclosing structure. The strip may in particular at least partially encompass the three-dimensional structure of the object. The distance between the surface of the object and the surface of the strip may have a constant value. In particular, the surface of the strip may be in direct contact with the surface of the object.

As outlined above, the straps are attached to the mounting means, respectively. As used herein, the term "attached to" is a broad term and is given its ordinary and customary meaning to those of ordinary skill in the art, and is not limited to a special or customized meaning. The term may particularly refer to, but is not limited to, the state of at least one object and at least one other object, wherein the object and the other object are in contact with each other in such a way that the object does not detach from the other object if no additional force is applied to the object or the other object to move the objects away from each other, and vice versa. In particular, the straps may be securely attached to the mounting means, respectively. Thus, the strap and the mounting means may be made of different materials, respectively. However, other embodiments may also be possible.

At least one of the two straps may be an elastic strap. Thus, for example, at least one of the two straps may be made of at least one elastic material. The term "elastic" may generally refer to the property of any object made of a material that is capable of deforming up to at least 10%, at least 25%, at least 50% or at least 75%, at least 100% or at least 150% of its dimension (such as the length of at least one section of the object) when stretched parallel to a surface with a force of up to 100 newtons, up to 50 newtons or up to 10 newtons, preferably between 10 newtons and 50 newtons. Thus, when the force is removed, the object may return to its original size and shape. The elastic material may be selected from the group consisting of: a silicone polymer; a silicone copolymer; an elastomer comprising at least one silicone copolymer; a rubber material, in particular neoprene; a polyurethane. However, other materials may be possible. In particular, the elastic properties of the strap may be achieved by a stretchable material, or by a combination of the limited elasticity of the material and the shape of the supporting strap elongated in one direction under load (e.g. via a curved cross-section).

Furthermore, in particular, at least one of the two strips may be made of at least one foam material. The term "foam material" may generally refer to any material formed by trapping air pockets in a material, which may in particular be a solid material. The foam material may have closed cells and/or open cells. The closed cells may form discrete pockets, each completely surrounded by solid material. The openings may be connected to each other. Thus, liquid can flow through the structure formed by the openings. Preferably, the foam material may have open cells. The openings may have an average size of 0.01 mm to 1 mm, preferably 0.1 mm to 0.5 mm. However, other dimensions may also be possible. Thus, sweat or other fluids such as water of the user or patient may be absorbed and the influence on the slip resistance of the band may be avoided.

The foam material may comprise at least one material selected from the group consisting of: a silicone polymer; chloroprene rubber; a polyurethane. However, other materials may be possible. Woven or non-woven fibers may also be used as the flexible but load-bearing material.

As outlined above, the two straps may be fixedly attached to each other. As used herein, the term "connectable" is a broad term and is given its ordinary and customary meaning to those of ordinary skill in the art, and is not limited to a special or customized meaning. The term may particularly refer to, but is not limited to, the property that an object can be placed into and physically next to another object. In particular, an object that is capable of being connected to another object may be in direct or indirect physical contact with the other object when connected thereto. As used herein, the term "fixably connected" is a broad term and is given its ordinary and customary meaning to a person of ordinary skill in the art, and is not limited to a special or customized meaning. The term may particularly refer to, but is not limited to, the state of at least one object and at least one other object, wherein the object and the other object are in contact with each other in such a way that the object does not detach from the other object if no additional force is applied to the object or the other object to move the objects away from each other, and vice versa.

Furthermore, the two straps may be releasably connected to each other. As further used herein, the term "releasable" in the context of mechanical connection refers to the fact that: the mechanical connection can be brought from the disconnected state (also referred to as unmated state) into the connected state (also referred to as mated state) at least once, preferably a plurality of times, and back into the disconnected state. Thus, the mechanical connection can be closed and released at will. In particular, the mechanical connection can be released by a manual operation only without using any tools. As an example, a force of no more than 50N, such as no more than 20N, such as no more than 10N, may be required in order to open the connection between the two straps. The force may be applied by a hand of the user or patient, or even a finger or fingertip.

The at least two straps may particularly be fixedly connected to each other by at least one of a button, a snap, a hook and eye, a magnetic lock, a plug buckle, a zipper. However, other closure mechanisms may be possible. Further, the length of at least one of the two straps may be adjustable. Thus, the holder may be adapted around a limb of a user or patient.

In a further aspect of the invention, a kit is disclosed. The kit comprises a holder as described above or as will be further described in more detail below. The kit further includes a medical device having at least one percutaneously insertable portion. For details of the medical device and the percutaneously insertable portion, reference is made to the description of the medical device above.

In particular, the medical device may be a drug device with an infusion cannula as described above. Thus, the kit may be an infusion kit. The term "infusion set" may refer to an assembly of parts required to perform any infusion. Thus, in addition to the infusion cannula, the infusion set may further comprise at least one fluid coupler for coupling the infusion set to at least one drug device, preferably to at least one drug pump. Thus, the infusion set may correspond to or may comprise a housing as described above or as will be described further in more detail below.

As described above, the housing of the medical device may comprise the at least one adhesive material. The adhesive material may be configured to attach the medical device directly to a skin site of a user or patient. Further, the adhesive material may be configured to attach the medical device to a mounting device of the holder. The housing of the medical device may be at least partially made of a rigid material.

Further, the kit may comprise at least one inserter unit. The term "inserter unit" may generally refer to any object configured to insert an element into body tissue of a user or patient. After the insertion procedure, the inserter unit or at least one component of the inserter unit may remain within the body tissue of the user or patient or may be removed from the skin site. In particular, the inserter unit may have an insertion cannula. The term "insertion cannula" may generally refer to any element that may be inserted into a body tissue of a user, in particular for the purpose of delivering or transferring a further element. The further element may specifically be a percutaneously insertable portion. Thus, the insertion cannula may specifically or may comprise a hollow tube or a hollow needle. Further, the insertion sleeve may be one of a slotted sleeve, a perforated sleeve, a sleeve having a curved shape. Other embodiments are possible. The insertion cannula may be configured to be inserted perpendicularly or at an angle of 90 ° to 30 ° to the body tissue of the user or patient, wherein the corner point of the angle corresponds to the puncture site of the insertion cannula on the body tissue. However, other embodiments may also be possible. In particular, the medical device may be received in an inserter unit. More specifically, the medical device may be at least partially enclosed by the inserter unit. However, other embodiments may also be possible.

The collar as described above may have a shape corresponding to the shape of the inserter unit. In particular, the collar and the inserter unit, in particular the bottom part of the inserter unit, may have complementary geometries that fit into each other. The mounting device, in particular the first side of the mounting device surrounded by the collar, may have a shape corresponding to the shape of the inserter unit, in particular to the shape of the bottom part of the inserter unit. Illustratively, the collar may enclose a circle and the inserter unit may also have a circular shape. However, other shapes may be possible. However, the average diameter of the area enclosed by the collar may be larger than the attachment surface of the medical device, so that the medical device may fit into the mounting device. The collar may be dimensioned such that there may be only a small play of the inserter unit within the holder, in particular within the collar. Thus, the collar may be configured to center the percutaneously insertable portion of the medical device. The collar may be configured to facilitate center alignment of the inserter unit. Thus, undesired penetration through the mounting device may be avoided.

In a further aspect of the invention, a method for mounting a medical device comprising at least one percutaneously insertable portion on a skin site of a user's limb is disclosed.

The method comprises the method steps as given in the independent claims and as listed below. The method steps may be performed in the given order. However, other orders of the method steps are also possible. Further, one or more of the method steps may be performed in parallel and/or in a time overlapping manner. In addition, one or more of these method steps may be repeatedly performed. In addition, there may be additional method steps not listed.

The method comprises the following steps:

a) mounting a holder as described above or as will be described further in more detail below on a skin site of a user's limb by fixedly connecting two straps to each other;

b) placing an inserter unit comprising the medical device on the first side of the mounting device such that the end of the percutaneously insertable portion and the aperture overlap each other; and

c) inserting the percutaneously insertable portion into the skin site through the aperture of the mounting device.

For further details regarding the medical device, the percutaneously insertable portion and the inserter unit, reference is made to the above description.

The medical device may be placed on the first side of the mounting means of the holder such that the adhesive surface of the medical device faces the first side of the mounting means of the holder. In particular, in step b), the medical device may be placed on the mounting device such that the medical device contacts the first side of the mounting device. Alternatively, in step b), the medical device may be arranged at a distance from the mounting device. The medical device and the inserter unit may be placed separately on the mounting device. For example, the medical device may be placed on the mounting device before the inserter unit is placed on the mounting device. Alternatively, however, the medical device and the inserter unit may be co-located on the mounting device.

In step b), the inserter unit may be placed on the mounting device such that the inserter unit is enclosed by the collar. During step c), an insertion mechanism of the inserter unit may be performed. If the medical device can be arranged at a distance from the mounting device. The mounting device may be moved towards the first side. Furthermore, after insertion of the transcutaneous insertable portion into the skin site, the inserter unit may be removed from the mounting device.

The housing may comprise the at least one opening, in particular the at least one exit point, for the percutaneously insertable portion. The medical device may be placed on the first side of the mounting device such that the exit point is located at the center of the aperture.

The proposed holder for a medical device, the proposed kit and the proposed method for mounting a medical device on a skin site of a user's limb provide a number of advantages over known devices and methods. Thus, in particular, the device and the method according to the invention allow adhering a medical device, in particular a housing of a medical device, to a skin site of a patient or user, while at the same time avoiding the risk of the skin of the patient or user being intolerant to the adhesive of the medical device housing.

In particular, the strip may be made of a non-slip material. Furthermore, the strip may be made of a material with good inherent elasticity. Further, the length of the strap may be adjustable. The holder may be mounted on the limb such that displacement of the holder may be avoided.

The medical device may comprise the at least one exit point for the percutaneously insertable portion and the medical device may be placed on the first side of the mounting device such that the exit point is located in the center of the aperture. For this purpose, the mounting means may comprise a collar. The inserter unit can be fitted into the collar with only a very small play.

After the inserter unit has been triggered and the transcutaneous insertion part has been placed in the skin site of the user or patient, the inserter unit may be removed. The housing may remain on the mounting means of the holder, but not directly on the skin site of the user or patient.

The straps may be made of a foam material, such as silicone polymer, neoprene, polyurethane. Thus, sweat of the user or patient can be absorbed and influence on the slip resistance of the band can be avoided.

The mounting means can be implemented very thin. In particular, the mounting device may have a thickness of 0.5 mm, since the medical device is configured to be directly attached to a skin site of a patient or user. In order to provide sufficient stability, the mounting means may be made of a rigid material, such as a hard plastic material.

Furthermore, the collar may be dimensioned such that stability of the medical device may be provided. The straps may be tensioned in a flexible manner over the limb. Therefore, the skin may bulge outward. However, this may be prevented or at least reduced by the rigid housing of the medical device. As a result, the flexible strip can be pressed against the skin and a secure fit of the sensor can be achieved.

Summarizing and not excluding further possible embodiments, the following embodiments may be envisaged:

example 1: a holder for a medical device, wherein the medical device comprises at least one transcutaneously insertable portion and at least one housing, wherein the holder comprises:

●, wherein the mounting device comprises at least one first side and at least one opposing second side, wherein the mounting device further comprises at least one hole from the first side to the second side, wherein the mounting device is configured to be attached to the housing of the medical device; and

● at least two straps, wherein the straps are attached to the mounting device, respectively, wherein the two straps are fixedly connectable to each other.

Example 2: the holder of embodiment 1, wherein the hole is a through hole.

Example 3: holder according to any of embodiments 1-2, wherein the first side of the mounting device comprises at least one flat surface configured to attach the medical device.

Example 4: holder according to any of embodiments 1-3, wherein the mounting device has a thickness of 0.1-2 mm, preferably 0.3-1 mm, most preferably 0.5 mm.

Example 5: holder according to any of embodiments 1-4, wherein the mounting means is at least partly made of a rigid material.

Example 6: holder according to any of embodiments 1-5, wherein the mounting device is made of a thermoplastic material.

Example 7: holder according to any of embodiments 1-6, wherein the second side of the mounting device is configured to face a skin site.

Example 8: holder according to any of embodiments 1-7, wherein the second side comprises at least one adhesive material.

Example 9: the holder according to any of embodiments 1-8, wherein the first side is configured to attach the medical device.

Example 10: holder according to any of embodiments 1-9, wherein the mounting means comprises at least one collar.

Example 11: the holder according to embodiment 10, wherein the collar forms a protrusion on the first side.

Example 12: the holder according to any of embodiments 10-11, wherein the collar is a circumferential collar.

Example 13: a holder according to any of embodiments 10-12, wherein the collar is configured to centre the percutaneously insertable portion of the medical device.

Example 14: holder according to any of embodiments 10-13, wherein the collar has a shape corresponding to the shape of the housing of the medical device.

Example 15: holder according to any of the preceding claims, wherein the holder is configured to be wrapped around a limb, in particular around an arm.

Example 16: holder according to any of embodiments 1-15, wherein the length of at least one of the two straps is adjustable.

Example 17: holder according to any of embodiments 1-16, wherein at least one of the two straps is an elastic strap.

Example 18: holder according to any of embodiments 1-17, wherein at least one of the two straps is made of at least one material selected from the group consisting of: a silicone polymer; a silicone copolymer; an elastomer comprising at least one silicone copolymer; a rubber material, in particular neoprene; a polyurethane.

Example 19: holder according to any of embodiments 1-18, wherein at least one of the two straps is made of at least one foam material, wherein the foam material comprises at least one material selected from the group consisting of: a silicone polymer; chloroprene rubber; a polyurethane.

Example 20: holder according to any of embodiments 1-19, wherein the at least two straps are fixedly connectable to each other by at least one of a button, a snap, a hook and eye, a magnetic lock, a bayonet buckle, a zipper.

Example 21: holder according to any of embodiments 1-20, where the strap and the mounting device are manufactured as one single piece.

Example 22: a kit, wherein the kit comprises a holder according to any of embodiments 1-22, wherein the kit further comprises a medical device having at least one percutaneously insertable portion.

Example 23: the kit according to embodiment 22, wherein the medical device is selected from the group consisting of: a drug device for delivering at least one drug to a user; a medical device for detecting at least one analyte in a bodily fluid.

Example 24: the kit according to any one of embodiments 22 to 23, wherein the medical device is a transcutaneous medical device.

Example 25: the kit according to any of embodiments 22-23, wherein the housing of the medical device comprises at least one adhesive material.

Example 26: the kit according to embodiment 25, wherein the adhesive material is configured to attach the medical device to the mounting device of the holder.

Example 27: the kit according to any one of embodiments 22 to 26, wherein the housing of the medical device is at least partially made of a rigid material.

Example 28: a holder according to any of embodiments 22-27, wherein the transcutaneously insertable portion is selected from the group consisting of: a sensor, preferably a glucose sensor; an infusion cannula, preferably an insulin infusion cannula.

Example 29: a method for mounting a medical device comprising at least one percutaneously insertable portion on a skin site of a user's limb, the method comprising the steps of:

a) Mounting a holder according to any of embodiments 1-21 on the skin part of the user's limb by fixedly connecting two straps to each other;

Example 30: the method of embodiment 29, wherein the medical device is placed on the first side of the mounting device via the inserter unit, wherein the inserter unit is removed from the mounting unit after inserting the percutaneously insertable portion into the skin site.

Example 31: a method according to any of embodiments 29 to 30, wherein the housing comprises at least one exit point for the percutaneously insertable portion, wherein the medical device is placed on the first side of the mounting device such that the exit point is located in the center of the aperture.

Drawings

Further optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Wherein each optional feature may be implemented in isolation and in any feasible combination, as will be appreciated by those skilled in the art. The scope of the invention is not limited by the preferred embodiments. Embodiments are schematically depicted in the drawings. In which like reference numbers refer to identical or functionally equivalent elements.

In the drawings:

fig. 1A to 1C show an exemplary embodiment of a holder for medical devices according to the present invention.

Detailed Description

Fig. 1A shows an exemplary embodiment of a holder 110 for a medical device 112 according to the present invention. A holder 110 is depicted in fig. 1B and 1C along with a medical device 112.

As shown in particular in fig. 1A, the holder 110 comprises at least one mounting device 114 and at least two straps 116, in particular at least one first strap 118 and at least one second strap 120.

The mounting device 114 includes at least one first side 122 and at least one opposing second side 124. In a mounted state of the holder 110, in which the holder 110 is fixedly connected to a limb (not shown) of a user or patient, the first side 122 may face the external environment of the user or patient and the second side 124 may face a skin site of the user or patient. Thus, the first side 122 may be a front side 126 of the mounting device 114 and the second side 124 may be a rear side 128 of the mounting device 114. The first side 122 may be configured to attach the medical device 112. Accordingly, the first side 122 may include at least one planar surface 130 configured to attach the medical device 112. Further, in particular, the flat surface 130 may be a rough surface 132. As a result, the adhesion of the medical device 112 to the holder 110 may be improved. Optionally, the second side 124 may include an adhesive material 134 configured to secure the mounting device 114 to the skin site during insertion of the percutaneously insertable portion of the medical device 112. The adhesive material 134 may be configured to adhere to the skin site for only a few minutes.

The mounting means 114 may particularly have a circular shape. The mounting device 114 may have a planar surface 130 as described above. As shown in fig. 1A, the mounting device 114 may have a thickness t of 0.1 mm to 2 mm.

In addition, the mounting device 114 includes at least one aperture 138 from the first side 122 to the second side 124. Specifically, the hole 138 may be a through hole 140. Illustratively, the mounting device 114 may have a circular shape, and the location of the hole 138 may correspond to the center 142 of the circle. However, other locations for the holes 138 may also be possible. The aperture 138 of the mounting device 114 may be configured to guide the percutaneously insertable portion from the first side 122 to the second side 124. Thus, the percutaneously insertable portion may penetrate a skin site of a user or patient. The hole 138 may particularly have a circular basic shape. However, other shapes may also be possible.

Optionally, the holder 110 may include at least one collar 144. The collar 144 may form a protrusion 146 on the first side 122. The collar 144 may have a height h of 1 mm to 100 mm. However, other dimensions may also be possible. In particular, the collar 144 may be a circumferential collar 148 that defines a closed line on the mounting device 114.

The first strap 118 and the second strap 120 may be attached to the mounting device 114, respectively. In particular, the first strap 118 and the second strap 120 may be disposed on opposite sides 150 of the mounting device. The first strap 118 and the second strap 120 may each be implemented as a strap 152. The first and second strap strips 118, 120 may be configured to form an endless belt 154 with one another. The first strap 118 and the second strap 120 may be fixedly connected to each other. Illustratively, as shown in fig. 1A, the first strap 118 may have at least one hole 156, in particular at least one through hole 158. The second strap 120 may then include a protrusion, such as a hook (not shown). The projections may be configured to hook into the apertures 156, thereby forming a connection between the first strap 118 and the second strap 120. In particular, the first strap 118 may include a plurality of holes 156 arranged in a row. Thus, the holder 110 may be adapted around a limb of a user or patient.

Fig. 1B shows the holder 110. For details of the holder 110, reference may be made to the description of fig. 1A above. Further, in fig. 1B, a medical device 112 is depicted. Specifically, a kit 160 is shown. The kit 160 includes a holder 110 and a medical device 112. Further, the kit 160 may include at least one inserter unit 164. The inserter unit 164 may be configured to insert the percutaneously insertable portion into body tissue of a user or patient. After the insertion process, the inserter unit 164 may be removed from the mounting device 114. This state is shown in FIG. 1C, which is further described in more detail below.

The medical device 112 includes the at least one percutaneously insertable portion (not shown) and at least one housing 162, as shown in FIG. 1C.

The inserter unit 164 may have an inserter unit housing 166. The inserter unit housing 166 may be configured to attach to the first side 122 of the mounting device 114. In particular, the inserter unit housing 166 may be configured to fit into the collar 144 with only very little play. The inserter unit 164 may include at least one button 168. The insertion mechanism may be triggered by pressing the button 168 toward the mounting device 114 (such as indicated by arrow 170). Thus, the percutaneously insertable portion may be at least partially placed within a skin site of a user or patient.

Fig. 1C shows the holder 110. For details of the holder 110, reference may be made to the description of fig. 1A above. Further, in fig. 1C, a medical device 112 is depicted. Specifically, a kit 160 is shown.

In fig. 1C, the housing 162 of the medical device 112 is shown. The housing 162 may be attached to the first side 126 of the mounting device 114, in particular to the surface 130. When the insertion mechanism is triggered by pressing the button 169 of the inserter unit 164, such as shown in fig. 1B, the housing 162 may be moved from the interior of the inserter unit 164 to the surface 130 of the mounting device. After removing the inserter unit 164 from the mounting device 114, the medical device 112 may be left on the mounting device 114. To this end, the medical device 112 may have at least one attachment component (not shown) capable of connecting the medical device 112 to the first side 122 of the mounting device 114, such as at least one adhesive surface.

The housing 162 may specifically be an electronics unit 174 with at least one component for one or more of: performing measurements using the sensor, performing voltage measurements, performing current measurements, recording sensor signals, storing measurement signals or measurement data, transmitting signals or measurement data to another device. The electronic unit 174 may be embodied as a transmitter or may comprise a transmitter for transmitting data.

The housing 162 may have an opening 176, specifically a through opening 178. The housing 162 may be placed on the first side 122 such that the opening 176 is centered in the aperture 138 of the mounting device 114, such as shown in fig. 1A. Thus, the insertion aid of the inserter unit 164, such as an insertion cannula (not shown), may be removed from the body tissue after insertion through the opening 176.

List of reference numerals

110 holder

112 medical device

114 mounting device

116 strap

118 first tape

120 second tape strip

122 first side

124 second side

126 front side

128 rear side

130 flat surface

132 rough surface

134 adhesive material

138 holes

140 through hole

142 center

144 collar

146 nose

148 circumferential collar

150 side

152 strip

154 circular belt

156 holes

158 through hole

160 set

162 casing

164 interposer unit

166 inserter unit housing

168 push button

170 arrow head

174 electronic unit

176 opening

178 through opening

Claims

1. A holder (110) for a medical device (112), wherein the medical device (112) comprises at least one transcutaneously insertable portion and at least one housing (162), wherein the holder (110) comprises:

at least one mounting device (114), wherein the mounting device (114) comprises at least one first side (122) and at least one opposing second side (124), wherein the mounting device (114) further comprises at least one aperture (138) from the first side (122) to the second side (124), wherein the mounting device (114) is configured to be connected to the housing (162) of the medical device (112); and

at least two straps (116), wherein the straps (116) are attached to the mounting device (114), respectively, wherein the two straps (116) are fixedly connectable to each other, wherein

The mounting means has a thickness of 0.1 mm to 2 mm.

2. Holder (110) according to claim 1, wherein the mounting means (114) has a thickness of 0.3 mm to 1 mm.

3. Holder (110) according to any of claims 1-2, wherein the mounting means (114) is at least partly made of a rigid material.

4. Holder (110) according to any of claims 1-3, wherein the mounting means (114) comprises at least one collar (144), wherein the collar (144) forms a protrusion on the first side (122).

5. A holder (110) according to claim 4, wherein the collar (144) is a circumferential collar.

6. A holder (110) according to any of claims 4 to 5, wherein the collar (144) is configured to centre the percutaneously insertable portion of the medical device (112).

7. The holder (110) according to any of claims 1-6, wherein at least one of the two straps (116) is an elastic strap.

8. Holder (110) according to any of claims 1-7, wherein the at least two straps (116) are fixedly connectable to each other by at least one of a button, a snap, a hook and eye, a magnetic lock, a bayonet buckle, a zipper.

9. Holder (110) according to any of claims 1-8, wherein at least one of the two straps (116) is made of at least one foam material, wherein the foam material comprises at least one material selected from the group consisting of: silicone polymers, neoprene, polyurethanes.

10. Holder (110) according to any of claims 1-9, wherein the holder (110) is configured to be wrapped around a limb.

11. A kit (160), wherein the kit (160) comprises a holder (110) according to any of claims 1-10, wherein the kit (160) further comprises a medical device (112) having at least one transcutaneously insertable portion.

12. The kit (160) according to claim 11, wherein the medical device (112) is selected from the group consisting of: a drug device for delivering at least one drug to a user; a medical device for detecting at least one analyte in a bodily fluid.

13. The kit (160) according to any one of claims 11-12, wherein the percutaneously insertable portion is selected from the group consisting of: a sensor; an infusion cannula.

14. A method for mounting a medical device (112) comprising at least one percutaneously insertable portion on a skin site of a user's limb, the method comprising the steps of:

a) Mounting a holder (110) according to any of claims 1-10 on a skin part of the user's limb by fixedly connecting two straps (116) to each other;

b) placing an inserter unit (164) comprising the medical device (112) on the first side (122) of the mounting device (114) such that the end of the percutaneously insertable portion and the aperture coincide with each other; and

c) inserting the percutaneously insertable portion into the skin site through the aperture (130) of the mounting device (114).

15. The method of claim 14, wherein the medical device (112) is placed on the first side (122) of the mounting device (114) via the inserter unit (164), wherein the inserter unit (164) is removed from the mounting unit (172) after inserting the percutaneously insertable portion into the skin site.